CHI Spotlight: CHI Recognizes Member Companies During 20th Anniversary

In honor of CHI’s 20th anniversary celebration, CHI President and CEO David L. Gollaher, Ph.D. will be recognizing member companies with commemorative plaques suitable for hanging or displaying at company headquarters.

 

Michael Mussallem and David Gollaher



On Feb. 19, CHI recognized Edwards Lifesciences’ leadership and dedication to improving California’s environment for biomedical innovation. Edwards Chairman and CEO Michael Mussallem, who serves as a CHI board member and past board chairman, received the plaque from CHI's Gollaher at the company’s Irvine headquarters. Edwards is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives.

 David Pyott and David Gollaher

On Feb. 26, Gollaher visited the Irvine headquarters of Allergan, where he presented a commemorative plaque to Allergan Chairman, President and CEO David E.I. Pyott, who serves as chairman of CHI. Allergan was honored for its continued commitment to California’s biomedical community. Pyott joined Allergan in January 1998 as President and CEO. As one of only three CEOs in the 63-year history of the company, Pyott has transformed Allergan from a small eye care business to a global specialty pharmaceutical and medical device company, with leadership positions in six medical specialties.

CHI is recognizing all of its members during this 20th anniversary occasion. Check your mailbox soon for the chance to display your own 20th anniversary plaque.

CHI-Advancing California biomedical research and innovation

Legislator Spotlight: Dr. Richard Pan (D-Sacramento)

Dr. Richard Pan

Since being elected to the Assembly in 2010, Dr. Richard Pan has worked with a variety of partners on legislation and other efforts that help Californians build safer, healthier communities.

As chair of the Assembly committee on health, Pan focuses on expanding transparency and oversight of government agencies involved in building healthier communities, as well as ensuring federal healthcare reforms are implemented effectively and efficiently in California.

Pan teamed up with Consumer Federation of California and the California Alliance of Retired Americans to remove expired medications and baby food from store shelves. And working with parents throughout California, Pan made sure schools and communities have the live-saving information they need to protect against vaccine-preventable diseases.

As director of the UC Davis pediatric residency program, Pan created Communities and Physicians Together to make UC Davis medical students available to work with families and local associations on projects that improve health in their neighborhoods. As co-founder and chair of Healthy Kids Healthy Future, Pan helped secure health, dental and vision coverage for more than 65,000 local children. He helped create the Sacramento Health Improvement Project, bringing together doctors, hospitals, clinics and community leaders to ensure that all Sacramento County residents have access to primary health care.

Pan continues to practice medicine at The Effort Oak Park Community Clinic, pursuing his passion for working with families to build healthier communities.

Q: What do you feel is the largest contribution the biomedical community has made to California?

A: The largest contribution is certainly the treatments that are saving lives and reducing morbidity. The side benefits, of course, are the major contributions to the California economy, certainly in terms of job creation and in reducing disease.

Q: What has your experience as a physician been like with our community?

A: I am a general pediatrician, so most of my work is on the primary care end. I’ve taken care of children with diseases that are very rare and require specialized treatments. We are in the midst of a genetic revolution and are better defining how genes attack disease. We are also in the very beginning stages of a neuroscience revolution.

In the end, we are going to turn this into treatments to help families. It’s going to be the biotech community that develops these treatments and helps disseminate them. That’s what is so important about our investment in biotech and being a leader in biotech here in California. We can do the research, go out and conduct studies, and, in the end, turn it into treatments that help families.

Q: How well do you think genetic sequencing is being integrated into the clinical practice?

A: What we have to do is turn that data into information. We are getting to the point, from what I understand, that you can sequence a person’s genome for $1,000. But what kind of information can we get out of that, and how can we use it to improve a person’s life? As we are trying to better figure out how the brain works, there’s tremendous opportunity there in terms of mental health, which is a very large chronic disease burden.

Q: What do you see as the University of California’s role in the biomedical community?

A: As a professor at UC Davis, I’ve seen it play a very important role in not only conducting research but in creating the future workforce. These tend to be very highly trained, doctoral-level people. If you look at Silicon Valley as a model, in terms of economic development, it is a really unique ecosystem in terms of creating an environment for innovation. So, one of the things we really need to encourage in California, as we’ve done for information technology in Silicon Valley and for arts and entertainment in Hollywood, is build collaborations for the biomedical industry. That kind of interaction is critically important. And it’s why I encourage investment in higher education. For all the wonderful resources we have here in California, a highly educated workforce is really our competitive advantage.

Q: How do you see national healthcare reform being implemented in California?

A: We are moving ahead with implementation of the Affordable Care Act. We want to expand coverage to more Californians and, of course, expand access to healthcare. In the end, we can do that. We can figure out what causes disease, we can develop the treatments, but people need to be able to access it.

As we look at how we try to reduce the cost of healthcare, the biggest opportunity for doing so is in the development of more effective treatments — and improving access to that. As we are looking at health reform going forward, we also need to consider how we better use our funds.

Q: What is the best way for the community to engage a member’s office

A: One way is to come and talk to us, and you can come visit the capital or district office. Educate the members about what you do, and what it takes to do it. There is very little time, given the term limits, for legislators to pick up on some of these topics and issues.

Q: As a healthcare provider and a legislator what do you see has the most pressing issue in CA?

A: Certainly one is getting our economy going right now. We are starting to see signs of improvement, but we need to continue to work on that. We need to plan for the future. To me, that is about how we can work with business and labor to try and improve economic productivity and infrastructure. We need to make sure we continue to maintain access to higher education. I really believe that we never have an excess of human talent. Part of having a productive workforce is having a healthy workforce, so we want to be sure we take care of our aging population.

We want to be sure we have a high-value business climate here in California. We will never be the cheapest place to do business, but we can be the highest value.

CHI-Advancing California biomedical research and innovation

 

Spotlight on Academic-Biomedical Industry Collaboration: UCSF Chancellor Susan Desmond-Hellmann



UCSF Chancellor Susan Desmond-Hellman

Susan Desmond-Hellmann, M.D., MPH became the ninth chancellor of the University of California, San Francisco on Aug. 3, 2009. An oncologist and renowned biotechnology leader, Desmond-Hellmann also holds the Arthur and Toni Rembe Rock Distinguished Professor appointment at UCSF. In her role as chancellor, she oversees all aspects of the university and medical center’s strategy and operations.

Prior to joining UCSF, Desmond-Hellmann spent 14 years at Genentech. From 2004-2009, she served as president of product development. In this role, she was responsible for Genentech’s pre-clinical and clinical development, process research and development, business development and product portfolio management. She also served as a member of Genentech’s executive committee, beginning in 1996. During her time at Genentech, several of the company’s therapeutics were approved by the U.S. Food and Drug Administration, and the company became the nation’s No. 1 producer of anti-cancer drug treatments.

Q: Industry and academia have traditionally operated at a different pace, with separate objectives. How have you addressed these challenges and what advice do you have for others who look to emulate your success?

A: The issue is more of having different goals, rather than a different pace, although quarterly earnings statements are definitely a driver that are foreign to most academics. We started by realizing that the old way of doing things – with pharmaceutical companies funding specific projects in a lab, then taking the results and never returning – doesn’t really work anymore. We need to start with an understanding of what academic researchers know and do well, which is advancing the core science on pathways and mechanisms of disease, and what industry partners know, which is how to take a discovery from a lab and turn it into a medicine.

We’ve had a number of partnerships, such as our agreement between Sanofi and our Diabetes Center, in which we’ve transformed that old model into a true collaboration, with the research starting here, then moving into the industry labs, then coming back for validation, and fostering communications throughout the process. Other partners have vast libraries of compounds or antibodies that are invaluable in our research. By working together, we can create a synergy that improves the science and also makes it more applicable for translation.

Q: How do you measure success of these academic/corporate partnerships?

A: We have many types of industry partnerships on campus, ranging from clinical trials to collaborations on very basic research that help us understand the mechanisms of disease. Success is measured differently for each of those. But my ultimate goal, which is shared throughout the UCSF campus, is to apply the most advanced science to improve the lives of people throughout the world. So for us, the real measure of these industry partnerships is whether they enable us to move faster and more effectively to translate the best science into real improvements for patients. That takes time, but that’s the ultimate success.

Q: What considerations do you make before deciding to partner with a pharmaceutical company?

A: There are many considerations, starting with how well our research is aligned in a specific field, and how well our strengths complement each other’s. As a public institution, it’s also very important to us that we establish some critical details up front, such as our faculty’s right to publish all results from their research – good and bad – and, where applicable, any intellectual property agreements. But, ultimately, we’re also looking for people who are aligned in our mission to translate great science into a real difference for patients worldwide.

Q: The Pfizer-UCSF partnership is unique in that it brought Pfizer labs to Mission Bay. How has the proximity helped advance key research?

A: Collaborations really are key to solving problems in science that we haven’t been able to solve, and it’s no secret that close proximity helps any relationship. Several industry neighbors have told us that being able to walk across the street, rather than calling someone from across country, is making a real difference in their collaborations with us.

Pfizer’s Center for Therapeutic Innovation, specifically, already has enabled UCSF and Pfizer to launch several key research collaborations at Mission Bay. Those include a project studying a treatment for a blood clotting disorder known as thrombosis, a therapy for a common and often deadly form of liver disease, known as non-alcoholic steatohepatitis, and new therapies for the devastating condition of pulmonary fibrosis, which scars the lungs and impairs normal breathing.

Q: At a time when federal support for basic research through the National Institutes of Health and National Science Foundation is declining, how might UCSF and academic institutes statewide continue to support groundbreaking research?

A: These are times when all of us are learning to be more creative. We’re doing our part by making sure we’re operating as efficiently as possible and supporting things like core research facilities on campus, so individual labs have access to top-of-the-line equipment, but can share that equipment with everyone else on campus.

We have been fortunate to still maintain strong research funding from the National Institutes of Health, which surpassed $500 million this year, but we’re also looking at other innovative approaches. Those include industry collaborations, as well as programs like our Program for Breakthrough Biomedical Research, which provides seed funding to support highly innovative basic science – the blue sky projects that take big risks but have huge potential. And we’re constantly finding ways to support entrepreneurs on campus, to help make that leap into translating advances in the lab into commercial products.

Q: At Genentech, you supervised some of the biggest successes in drug development history. Are there parallels to be made between your business experience and the challenges you face as a chancellor?

A: As at Genentech, at UCSF I oversee a team of exceptionally talented, motivated people. As chancellor, my goal is to provide all of our faculty, whether they are basic or clinical researchers, educators, or clinicians with the support they need to succeed in their work. This means understanding the challenges and obstacles they face and identifying ways to help them address them. It also means identifying, from my more distant perspective, broad opportunities that individual faculty members may not see to advance their work.

Given my own background, I’m very interested in translational medicine, moving our research discoveries toward the clinic, and much of my effort focuses on facilitating this effort.

Q: If you could change policies at the state or federal level, what would your priorities be?

A: I’m very interested in ensuring that federal funding for research is sustained and at least keeps pace with inflation, in order to support our thriving research enterprise. Also, I would like to see the FDA continue to work on streamlining its approval process, which would help move drugs more quickly to market, while also making it more appealing for venture capital to continue to invest in this industry. I’d also like to see more collaboration between federal funding agencies, universities and regulatory agencies, and to see more investments in innovative science.

CHI-Advancing California biomedical research and innovation

A Conversation with Allergan CEO David Pyott

David Pyott

Allergan CEO, medical aesthetics pioneer and CHI Chairman-Elect David Pyott tells us what the business of beauty can teach the medical device industry about consumer-centric medicine. This article orginally appeared on MassDevice.com. It has been republished here, in part, with permission.

Hear from Pyott in person when he joins a panel of biomedical industry executives for the MassDevice Big 100 West. CHI President and CEO David L. Gollaher, Ph.D., will moderate the panel Dec. 11 in Newport Beach. CHI members receive a discount to attend. Click here for more information or to register with code CHI.

Allergan CEO David Pyott has described himself as a "mountaineer," a "born marketer," and a bit of a masochist, but there's one thing the man undoubtedly is: A pioneer of the medical technology world.

After taking the reigns of the Irvine, Calif.-based medical aesthetics giant in 1998, Pyott quickly set about transforming an eyecare company into a global juggernaut that pulls in north of $5 billion a year with a diverse line of specialty pharmaceuticals and medical devices. Pyott did so not by doubling down on conventional wisdom, but by changing the playbook. Much to the chagrin of some company executives at the time, he cut costs by 33 percent, shed Allergan's contact lens solution business and concentrated significant resources on a little-known product in the company's pipeline called Botox.

Today no one needs any introduction to Botox, which is as much a cultural phenomenon as it is a medical product. But the lessons of the drug and Allergan's medical aesthetics business, which makes up 40 percent of its sales (all paid for directly by consumers) could hold some significant lessons for the broader medical device world.

We sat down with Pyott recently to discuss how medical aesthetics could change the way medical devices are sold and marketed to patients.

MassDevice: When Allergan bought InaMed in 2006, you said, "Now Allergan is the global leader in medical aesthetics." I'm hoping you can define what the term "medical aesthetics" means to you and how it fits within your overall approach to the Allergan business.

David Pyott: I think I can be speaking accurately if I can say really I invented that term. I was literally sitting there, because I'm a recovering marketer, thinking "What on earth does one call the genre of Botox and its competitors?" Latisse was still a twinkle in my eye at that stage. Clearly it had something to do with improvement of appearance and so I liked the word aesthetics. But I wanted to make it very clear. This is aesthetics delivered through a physician, hence, why I chose the word medical. Breast implants were long way away from any form of cosmetics that you'd buy at the Macy's counter. But the further you got to that direction, such as physician-dispensed creams and lotions, that's probably the closest point to where the world of retail is just around the corner.

MassDevice: When you coined the term, how were these classifications of drugs and devices generally referred to in the medical community? Was it sort of ambiguous?

DP: I would say the markets were very small and I'm not sure that anybody had thought of the overarching market in such a holistic way. People were very much drilled in on the individual product segments. So, clearly by 2006 Botox had grown enormously, because we got the approval in 2001. By that stage it was probably roughly half a billion in sales. And dermal fillers, in my view, hadn't really happened in the United States.

At that point, the European market, particularly Central Europe, was probably two and a half times the consumption per capita of broader North America. And when we brought Juvederm into the Canadian and U.S. market, it probably took us three years to get up to European consumption levels. So, you can see that there is kind of a whole history in the background here of creating markets where really nothing had existed before.

MassDevice: Was there an a-ha moment for you in the medical aesthetics field, or is it directly tied to Botox? When you took over Allergan, it certainly wouldn't have been referred to as medical aesthetics company – it was more eyecare.

DP: I'm pretty sanguine about these things, because people often claim instant brilliance and I'm not sure I would ever subscribe to that theory. I think there are moments that are similar to hiking in the Sierras, a pass in the mountains as you get higher and higher

The way I would see it is if I look at that journey, when I came to Allergan, Botox was literally an orphan drug. And I think it was probably an orphan drug in the minds of a lot of the senior management as well. And this was before the heyday of orphan drugs.

I realized, listening to both people internally and then customers, that there was a huge opportunity for Botox, not only cosmetics but therapeutic, which is a different topic. That led to having investments and getting cosmetics through the FDA. So that really started in early 1998 and we got the approval three years later. And that was the beginning of the journey.

MassDevice: In one of your recent earnings calls you discussed the resiliency of the dermal filler and the Botox markets, the breast implants in markets like Southern Europe, which you seemed a little bit tickled by. Is there a broader lesson here?

DP: When we look back, the great recession year for us was 2009. When we entered 2009, of course, none of us knew how bad it was going to be. So we were pretty cautious and the first half of that year, the whole company declined about 10 percent.

But what was really interesting was that the recession, particularly in the U.S., around the world, some places you could argue maybe it never happened. Like China, Brazil, they felt they had a recession, but it was like hitting a little pothole, a very small one, and just bounced right through it. In the U.S., our market stopped declining five months after it started, and then it re-accelerated. So when we got to 2010 – in fact all of our product markets globally were already bigger than in 2008. Which, of course, I would never have dared to predict in early 2009. I was thinking, "Oh man, this is going to take years until we get back to the high-water mark."

Partly it was because of the segments of society that we probably addressed at that time, in terms of our penetration. So typically, this is kind of middle-top for income. It's not only women, probably 10 percent of the consumption's male – but women's repertoire of how they want to keep themselves looking a bit younger than their driver's license or passport, or birth certificate would say. Of course, the idea of going back to being the way you were before is not really a great option for most people.

During that phase, I literally heard about people postponing or canceling vacations or crimping on fine dining, basically to save up for Botox and Juvederm. We used to hear lots of that.

MassDevice: Well that's interesting too, because in the orthopedics business, we've heard tons of stories about people postponing all acute surgeries, and all other medical markets seemed to contract a bit there.

DP: I think we saw a bit of that with breast augmentation surgery. That was the one that was the most heavily hit, because of course there's somewhere a good correlation to what is the out-of-pocket spend.

I think another comment you made which I'd like to address was, "Why is Europe doing so well?" Well, my experience has been that, basically, innovation can trump a lot of economic headwinds. We have syndicated market research, so we have the very fix on the European market and of course we know our sales even better. We're growing somewhere between – depends on the country – two and three times the speed of the market in Europe.

MassDevice: You're a born marketer, I mean, when you're looking at these indications, and these products that you're going to place into there, when you look at the specialties, do you pick one that fit within that specialties where you can communicate directly to the patient? I saw some of the direct consumer advertisings you had for Botox for migraines, so you're going directly to the patient there and addressing their pain point.

DP: I think really where we start is where is the technology? Where do we have a solution that in some manner improves patient care? That's always the starting point and maybe because we've looked carefully and found, time and time again we found these solutions. If I cross over, to say, Botox for a chronic migraine, one of the reasons that we chose to go down that road was because so many migraine patients have just given up. They've tried treatment after treatment, on to doctor after doctor and they're basically at home miserable. We know from consumer research we've done that these people, when they're not in sort of maximum pain, because they're probably to some degree forced to be inward-looking. Because they don't go out so often because they're in terrible pain, so they're on the Internet a lot.

MassDevice: When we spoke to Align Technology CEO Tom Prescott, he said that the medical device industry used to look down on the private pay model. Do you think there's still that attitude?

DP: I don't think so. I mean if you look at the pressures that are facing our industry, whether it's device or pharma, I think there are huge pressures. I think a lot of both; well, industry executives realize that private pay could be an escape valve. How do you get out of some of these pressures? And we've seen that in Europe in a different field, another example of how we go to and fro between cash pay and reimbursed.

In this country, artificial tears are paid for out-of-pocket. You just go down to Walgreens and you can find it on the shelf. Now, you probably as a consumer have in the back of your head that the optometrist or the ophthalmologist recommended you brand A or B, hopefully ours. We happen to be the world's No. 1 producer of artificial tears. But then in Europe, it's very interesting. There there is a bifurcated model where historically the government has paid for tears.

But, more recently, certain governments have either completely de-reimbursed tears or made it possible in parallel to introduce, I'll call it non-price regulated tears, I mean you still have the approval, right? But then you have the ability to price-relate. There's another example of where you can kind of go down two streets.

It shows there are ways to segment markets and of course you've got to do it within the regulatory process of that individual country.

You can see there are many different angles to this question about how medical aesthetics can translate. You can come in through, "What is the regulatory framework?" You can come in through, "How do you drive the consumer element?" if you like delivering consumer or consumerized medicine. Then I suppose this is just the whole backdrop of how do you innovate, right?

MassDevice: I like the idea of how you pioneer delivery to a consumer market because there's a great desire in all the companies that we cover for growth. And it feels like they are just throwing products against the wall, seeing if they can keep the same model or expand to a different country.

DP: Yeah, well, I mean to end on a high note, I would say, hard times often are great times to get creative, right? Because you sit there and go, "This isn't enough, we've got to find something new."



CHI-Advancing California biomedical research and innovation

Legislator Spotlight: Rep. Jackie Speier (D-Hillsborough)



Rep. Jackie Speier



Rep. Jackie Speier, D-Hillsborough, has championed numerous issues of importance to California's biomedical community, including reforms to the U.S. Food and Drug Administration and funding increases for the National Institutes of Health. Speier, who serves as co-chair of the Biomedical Research Caucus in the House of Representatives, represents a congressional district that includes some of the biggest names in biotech and academia, from Genentech to UCSF. In 2012, Newsweek named Congresswoman Speier as one of the 150 fearless women in the world. During her more than 30 years of public service, she has passionately advocated for women's issues and health access.

Q: You are aware of the numbers regarding this industry: 270,000 jobs, 2,300 California biomedical companies, $2.7 billion in VC funding, $7 billion in NIH funding. But when you think about the California life sciences sector, what does it mean to you?

A: It means the difference between life and death, in many respects, because the drugs and medical devices that are being created are saving people’s lives and fundamentally transforming our ability to tackle the most serious and deadly diseases of our time. The life sciences sector is one of the strongest examples of the innovative spirit that is a trademark of our state. Every day, the brightest minds in our universities are unlocking scientific discoveries that will lead to companies of tomorrow and cures that were unimaginable only decades ago. This industry has become a shining example of all that is possible when we pair bright minds with a commitment to improving people’s lives. But this industry is not without its challenges. There is much we still need to do to ensure that American patients have access to these life-saving discoveries. I don’t want to say to my constituents, “You are going to get better care in Europe.” We have to be diligent and thorough, but we also have to be willing to provide compassionate care, too.

Q: How do you plan to reinstate science as a government priority at a time when Congress is proposing cuts across the board?

A: It is a priority. And it’s a priority for a vast number of Americans. You ask American voters whether or not they want to see science as a No. 1 priority and it would be overwhelmingly yes, particularly when someone is diagnosed with a very serious medical condition. So, how do you convey that to the majority right now in the House that believes that we should slash funding to the NIH, FDA & CDC? I think we all have to do a better job of conveying the link not only between federal funding for medical research and scientific progress, but also, economic growth. The statistics really speak for themselves. In 2010 alone, the $26.6 billion invested by taxpayers in NIH research grants generated $68 billion in new economic activity and supported nearly 490,000 public and private sector jobs, representing a 150 percent single-year return on public investment. This isn’t just about science and saving lives, this is about supporting our economic growth and recovery. Cutting funding for these agencies isn’t just bad for our health as a nation, it’s bad economics.

There is also much we can do to streamline the FDA approval process, while still being thorough, and creating the pathways for companies to succeed. I make a point of visiting life science companies in my district, easily three or four a month. These companies are doing such remarkable work. Their work will potentially reduce the cost of healthcare because they are creating a smarter, more efficient healthcare system through their innovative advances. For example, we know that chemotherapy does not work on 80 percent of tumors, and, therefore, most patients would either be just as well off without that treatment altogether or benefit more from an alternative medical option. But even though we have this information, we still spend $80 billion each year on cancer therapies. This isn’t just about money, this is about sparing patients a horrific experience to try and stay alive. Part of our job is to convey that personalized medicine is not an add-on to healthcare. It is a refinement of providing healthcare to patients so that we are not administering certain therapies to people that are not going to work.

Further, I envision a system where this wasted money is redirected to research that will result in additional treatment options tomorrow so chemotherapy isn’t their only recourse.

Q: You have championed many bills to support biomedical research funding, including SBIR and STTR grants that promote entrepreneurship. Talk about the importance of these to you.

A: I think these grants give fledging companies an opportunity to survive, and, oftentimes, to thrive. It advances our knowledge base and the science that allows us to then build the next generation of life sciences companies with new discoveries that are going to improve the quality of life.

I oftentimes tell people about the meeting of a venture capitalist, Bob Swanson, and Herb Boyer, a UCSF professor. It was a quintessential San Francisco story – two guys drinking beers at Perry’s. At the end of a three-hour meeting, they didn’t just shake hands and found a company; they founded an industry with hundreds of thousands of employees in this region. So, why wouldn’t we want to promote more relationships like that which might just create the newest industry that’s going to improve our health?

Q: San Mateo County received $75 million in stimulus funds from HHS. Much of the money went to organizations including SRI International, Applied Biosystems, Epitomics and others. Have these projects lived up to their potential?

A: Actually, San Mateo County probably received a great deal more because stimulus funds also supported our public health system and UCSF collaborations with businesses in this county. To be honest, I’m not familiar with the outcome of the grants that are mentioned in the question but I can say this about grants for science in general: It’s almost always money put to good use. The returns on the investment almost always reverberate across many years, if not decades. For example, there are people at UCSF whose surgeries are going to be much more precise because the PET machine now exists. As I visit life science companies throughout my district, I am frequently told that SBIR grants were the source of a lot of development funding for new tests and treatments that have moved forward in this county, and from here to the four corners of the world. SBIR got a big boost through the stimulus bill. In sum, if you give a genius a dollar, it’s likely she’ll turn it into at least two dollars of value for taxpayers. The challenge is to recognize that the lead times are long, the path to commercialization too arduous in many instances, and the commitment of Congress to predictable funding weak. Rather than asking if the projects live up to their potential, perhaps we should ask if we do ourselves any favors by shortchanging human genius.

Q: You heard a lot over the past couple years about the issues of consistency and unpredictability at the FDA. You communicated with the FDA and helped convey dialogue with the industry’s thought leaders to discuss how we can address those issues while also maintaining the high standards of safety that the public expects and deserves. How do we ensure that that dialogue continues and that those improvements are implemented?

A: We need to set high expectations of our members of Congress to keep engaged with the FDA and create opportunities for the FDA and the life sciences industry to interact. Safety and efficacy are essential, but the process required to receive those results should also be predictable. The last thing we want is for the industry to come to a screeching halt. PDUFA and MDUFA were great bipartisan efforts this year. Vigilance is absolutely key to making sure that improvements at the FDA continue, we cannot afford to take our eye off the ball. I can guarantee you that Congresswoman Anna Eshoo and I will be monitoring the relationship between FDA and the life science companies for years to come.

Q: What are you most proud of as a Bay Area native and graduate of two UC campuses?

A: I am so grateful that I was the beneficiary of advanced education at two UC campuses that were affordable. Unfortunately, we can’t say that today. My education at UC Hastings College of Law cost me $700 a year. If you account for cost of living, it should cost about $2,700 a year. The average Hastings student right now is paying $47,000 a year. We have made it unaffordable to get the kind of education I got 40 years ago. Likewise, if advanced degrees in scientific fields become prohibitively expensive at our state universities we are going to have a serious problem producing the brain trust that has historically created the life science companies that call our state home. I think we have a huge responsibility to turn this trend around.

CHI-Advancing California biomedical research and innovation

CHI 2012 Keynote Spotlight: Dr. Mark Smith, President and CEO, California HealthCare Foundation

Dr. Mark Smith

Dr. Mark Smith, a board-certified internist who has served as president and CEO of the California HealthCare Foundation since its formation in 1996, will keynote CHI 2012, the annual meeting of biomedical executives, entreprenuers, investors and policymakers. The event, happening Nov. 8 at Gilead Sciences in Foster City, Calif., brings together policymakers with representatives of CHI’s member organizations to discuss critical issues and opportunities facing the biomedical community. Click here to register by Friday, Nov. 2.

CHCF is an independent philanthropy headquartered in Oakland, Calif. dedicated to improving the health of Californians with special concern for the underserved.

Q: In a blog post for JAMA Forum earlier this year, you argue that, regardless of the Supreme Court decision or the results of the upcoming presidential election, health reform is already happening, and will continue. Explain to our audience, briefly, what you mean by this?

A: While the outcome of the presidential and congressional elections matters a great deal in some areas of healthcare policy, there are number of big trends in the delivery system that are a result of forces that are independent of these elections. In particular, cost pressures on every sector of healthcare will only intensify, no matter what the outcome of the election. Consolidation (of hospitals with each other, hospitals with physicians, and physician groups with each other) will continue. Novel arrangements between payers and provider systems aimed at reducing spend will persist; and consumers, spurred, in part, by growing out-of-pocket responsibilities, will become more and more price sensitive and more demanding of convenient customer service attributes which they have come to expect from other aspects of their lives.

Q: The ACA gave rise to a lot of talk about cost containment. How big of a role do you suppose personalized medicine will play in driving down costs?

A: Too soon to tell. I can certainly imagine circumstances in which the ability to accurately predict an individual patient's response to an expensive medicine, say chemotherapy or biologic anti-inflammatory, may reduce expenditures on ineffective medicine, despite the expense of the initial test. But I can also see circumstances in which breathtakingly expensive personalized approaches provide only marginal increases of effectiveness with dramatic increases in costs. The good news (from the perspective of cost control) is that I think the approval and reimbursement environment of the future will be more on evidence and less on marketing.

Q: We stand at a time when policy often lags the pace of scientific advance. Genetic sequencing and biomarkers are examples. How do we keep the two in unison?

A: We can't. No matter how much we'd like to do so, the policy environment will never be as dynamic, nimble, or unpredictable as the breakthroughs in biomedical science. So, the question is not so much how we keep them in unison as how we can keep the policy environment from getting decades behind the science, as it is in many areas now. It will require new approaches to conditional approval, post-approval surveillance, collaborative funding of trials, etc. The most hopeful development is the progress of digitized medical records, computing power, and rapid learning systems which can compress the time needed for thoughtful collection, review and analysis of clinical data and, in some instances, replace traditional clinical trials.

Q: If you could change a single healthcare policy, at the state or federal level, what would it be and why?

A: Begin to develop a single national policy with regard to scope of practice, so that improvements and advances in the productivity and capacities of healthcare workers and patients themselves would not have to be battled out board by board, state by state.

Q: What are you most looking forward to in anticipation of CHI 2012?

A: The election will be over, some uncertainty will be reduced, and we can look forward to how to work together to strengthen the healthcare system while making it more affordable.

CHI-Advancing California biomedical research and innovation

Event Spotlight: USC Body Computing Conference 6.0

USC's Dr. Leslie Saxon and Ken Persen of Cameron Health showcase implantable defibrillation technology at the USC Body Computing Conference. Photo by USC Center for Body Computing.





To prosper as a competitive society, we have to become experts in managing data. For physicians, that data has to be clinically relevant.

Healthcare executives shared these insights and more Oct. 5 at the annual USC Body Computing Conference. CHI is a proud supporter of the annual conference, which gathers leaders from medicine, entertainment, telecommunications, kinesiology, and the regulatory world to shape the future of wireless medical solutions.

For the sixth year, Dr. Leslie Saxon, chief of the division of cardiovascular medicine at the Keck School of Medicine and founder of the USC Center for Body Computing, led a discussion about wireless health and how it is changing healthcare monitoring and delivery.

Thomas E. Jackiewicz, senior vice president and chief executive officer for USC Health, said he expects that personalization will be the standard of care for cancer care in the next five years. Genomic medicine will outpace the federal meaningful use electronic health records incentives program, he said.

Dr. David Agus, professor of medicine and engineering with USC and co-founder of personal genetics company Navigenics, shared how far the industry has come in advancing medical treatments by reminding the audience how early pregnancy tests were administered – using rabbits.

Today, he said, we can sequence tumors and gather data that informs healthcare decision-making.

“We now have the technology to look at all the proteins in the body,” he said.

Some of the technologies showcased by conference presenters included brain monitoring devices to get inside the minds of elite athletes, technology platforms that allow for better integration of the hospital patient in team discussions and treatments, and devices for wirelessly monitoring the body’s vital signs in real-time.

One of the more interesting concepts on display at the conference was Nigel, a Mini Cooper equipped with 230 sensors and an iPhone app to monitor driver habits and even create specific driving games or suggest activities for each of the car’s drivers. The idea could also apply to a driver’s health, said Saxon, by tracking the driver’s heart rate and increasing awareness about how the body responds to a song, for example. There is a “huge unmet need” for patients to be better connected with their own health, she said.


Sam Agutu says Changamka has changed the healthcare paradigm for uninsured Kenyans. Photo by USC Center for Body Computing.




Sam Agutu, managing director and CEO of Changamka Microhealth Ltd., captivated the audience with his healthcare “by the slice” approach to combining mobile money systems with prepaid health cards that allow uninsured Kenyans to pay only for the healthcare services they need, at pre-negotiated rates.

During a question-and-answer session with a senior level U.S. Food and Drug Administration representative, attendees asked about the various pathways for approval of these new technologies. Megan Moynahan, associate director for technology and innovation at the FDA, encouraged the audience to continue to push the boundaries of innovation so that the agency is forced to reckon with the latest cutting-edge ideas.

The USC Center for Body Computing, which runs the conference, studies, incubates, and creates wireless health products with other USC schools and corporate partners. It specializes in creating innovative solutions for chronic disease management, sports monitoring, mHealth and gaming and entertainment. Click here for more information.

CHI-Advancing California biomedical research and innovation

Event Spotlight: O’Reilly Strata Rx Conference

CHI proudly supports Strata Rx, a conference taking place Oct. 16-17 at the Hilton San Francisco Union Square that will bring together experts and innovators in data science and healthcare, crossing traditional industry boundaries and uncovering insights on the emerging analytic approaches that can help solve some of healthcare's biggest challenges. Click here for more information on the conference and to receive the CHI member discount. In today's CHI Blog interview, event co-chairs Colin Hill and Julie Steele discuss their expectations for the conference, and some of the most pressing issues surrounding Big Data.



Colin Hill

Colin Hill is the CEO and co-founder of GNS Healthcare, a pioneer in Big Data analytics in personalized medicine and healthcare. He writes the Healthcare 2020 blog for Forbes. In 2004, Hill was named to MIT Technology Review 's TR100 list of the top innovators in the world under age 35.

 

Julie Steele

Julie Steele is the content editor at O'Reilly Media and co-author of Beautiful Visualization and Designing Data Visualizations.



 

Q: Talk about how this conference was conceptualized, and what your intentions are for it this year and beyond?

Steele: This conference was borne out of a larger conference called Strata. In accordance with Tim O’Reilly’s mission to work on things that matter, we looked at healthcare, specifically, as an area in which data science really has the potential to have significant impact for the better. This conference is designed to start some of the conversations between people who, traditionally, are in different silos of the healthcare industry. They may be computer scientists or they may be coming from a data science background and we want to get those conversations started so that collaboration and cooperation can happen.

Hill: Healthcare represents almost 20 percent of U.S. GDP. It’s the single largest category of the economy and is growing faster than anything else, while, at the same time, the U.S. is in the bottom half in terms of health outcomes. How can this be and what does this mean for technology and for data?

Q: Tell me who should attend the conference, and why.

Steele: It’s a mash-up of people from different corners of not just the health universe but the data and technology universe. You have health insurance executives but you also have data scientists participating. We really expect a wide audience of stakeholders including patients and providers. This conference gives them the opportunity to collaborate on some of today’s most pressing Big Data issues.

Q: Give me few examples of the kinds of healthcare organizations that have developed a strategic approach to Big Data.

Hill: In a way, healthcare is still in its infancy with Big Data because it is still a lot more about the research and the gathering of the data. We are beginning to see more interesting examples of data turned into decision making and interventions for patients. Stage 4 cancer patients, who would normally be left to die, now have a chance to find, outside of the standard of care, an intervention that works really well for them.

I think 23andMe and PatientsLikeMe, a community-based personalized medicine platform, are interesting examples of how organizations have been able to essentially reproduce research that took a very long time, find genetic associations for disease risk and use a crowd-sourcing-like approach.

Aetna just announced Aetna Innovation Labs, and, with that, a deal with GNS Healthcare around using data to manage metabolic syndrome to create a more personalized approach to disease management.

Another company is Foundation Medicine. They are doing some really innovative work, when it comes to cancer drug matching, leveraging DNA sequencing in a way that is giving patients a chance to respond beyond just the standard of care. In fact, we are using it on my father’s prostate cancer right now, so we have some intimate and personal knowledge of how Big Data is actually changing the paradigm.

Q: It is clear we don’t want to pay for ineffective treatment. What potential does Big Data have for outcome-based payment models?

Hill: That’s a great question. I think that’s absolutely critical. With all the hype and excitement about accountable care organizations and even value-based pricing that you're seeing with pharma, such as the Johnson & Johnson Velcade deal with the U.K. as of a few years ago, this really starts to force the use and the implementation of Big Data analytics to determine what’s actually going to work for which patient. I see Big Data at the core of answering these problems.

Q: Is there ever such thing as too much data?

Steele: I would frame it this way: The only data that is useful is the data that you can analyze and use to make better decisions. That’s the goal of all of this.

Hill: I would generally say no. We are always hungry for more data, but it absolutely has to be the right kind of data and we have to be able to find it and you can’t spend trillions of dollars storing it.

Q: From the O’Reilly report How Data Science is Transforming Health Care: “Data becomes infinitely more powerful when you can mix data from different sources: many doctor’s offices, hospital admission records, address databases, and even the rapidly increasing stream of data coming from personal fitness devices.” How far away is this?

Hill: On the drug development and biomedical research side, combining of data types is already happening, whether it is attempts to discover predictive markers to stratify patients in trials or to determine in a patient care setting who is going to respond to a different drug.

We are already seeing a lot of studies that are combining multiple data modalities where it is DNA sequencing, either single-nucleotide polymorphism or full-genome sequencing, combined with gene expression and metabolite profiling and clinical outcomes. It’s starting to become somewhat standard for certain diseases. In terms of healthcare data, when you’re talking about electronic medical records, claims data, clinical outcomes and such, you’re starting to see more combinations of companies, such as Humedica and Explorys, combining these data types. There’s also some focus on extracting data, closer to real-time, out of hospitals, combining that with longitudinal claims data that the hospitals process in order to get paid.

It’s going to take a bit longer for mobile health data to become real. We are still on the fringes of what really matters and what’s worth paying for. In my opinion, we are three to five years away from that becoming real. I think within five to 10 years it really becomes game changing.

CHI-Advancing California biomedical research and innovation